Catalog Number

-

Brand Name

Invia Transparent Film

Version/Model Number

201.0932

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K170088,K170088,K170088

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

503d527a-86f0-4b1d-816b-c64fbc7e46ed

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 07, 2017

Package DI Number

07612367050241

Quantity per Package

20

Contains DI Package

07612367050234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-